07-12-2017 дата публикации
Номер: US20170348342A1
Автор:
BERREY MIRIAM MICHELLE,
Casteel Melissa Jean,
Cleary Darryl G.,
Hebner Christy M.,
Hindes Robert G.,
Mo Hongmei,
Oliyai Reza,
Pakdaman Rowchanak,
Ray Adrian S.,
Reynolds Charles J.,
Stefanidis Dimitrios,
Symonds William T.,
Zia Vahid
Принадлежит:
Disclosed herein are a composition and unit dosage form for the treatment of hepatitis C virus (HCV) infection comprising GS-7977 and at least one pharmaceutically acceptable excipient, as well as methods for making said composition and unit dosage form. Also disclosed herein is a method of treating a subject, preferably a human, infected with hepatitis C virus, said method comprising administering to the subject for a time period an effective amount of GS-7977 and an effective amount of ribavirin. In one aspect, the method comprises administering to the subject an interferon-free treatment regimen comprising an effective amount of GS-7977 and an effective amount of ribavirin. In a particular aspect, the method is sufficient to produce an undetectable amount of HCV RNA in the subject for at least 12 weeks after the end of the time period. 1. A pharmaceutical composition comprising:a) about 25% to about 35% w/w of GS-7977; andb) at least one pharmaceutically acceptable excipient.2. The composition according to claim 1 , wherein the composition comprises about 30% to about 35% w/w of GS-7977.3. The composition according to claim 1 , wherein the composition comprises about 30% w/w of GS-7977.4. The composition according to claim 1 , wherein the composition comprises about 33% w/w of GS-7977.5. The composition according to claim 1 , wherein the composition comprises crystalline GS-7977.6. The composition according to claim 5 , wherein the crystalline GS-7977 has XRPD 2θ-reflections (°) at about:(1) 5.2, 7.5, 9.6, 16.7, 18.3, and 22.2;(2) 5.0, 7.3, 9.4, and 18.1;(3) 4.9, 6.9, 9.8, 19.8, 20.6, 24.7, and 26.1;(4) 6.9, 9.8, 19.7, 20.6, and 24.6;(5) 5.0, 6.8, 19.9, 20.6, 20.9, and 24.9;(6) 5.2, 6.6, 7.1, 15.7, 19.1, and 25.0; or(7) 6.1, 8.2, 10.4, 12.7, 17.2, 17.7, 18.0, 18.8, 19.4, 19.8, 20.1, 20.8, 21.8, and 23.3.7. The composition according to claim 6 , wherein the crystalline GS-7977 has XRPD 2θ-reflections (°) at about:(1) 5.0, 7.3, 9.4, and 18.1; or(2) 6.1, 8.2, 10.4, ...
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